Breast Cancer Clinical Trial
S1200: Acupuncture, Sham Acupuncture, or Wait List for Joint Symptoms Related to Aromatase Inhibitors in Pts W/Early-Stage Breast Cancer
Summary
RATIONALE: Acupuncture may help relieve joint pain.
PURPOSE: This randomized phase III trial studies acupuncture to see how well it works compared to sham acupuncture or waitlist in treating patients with joint pain related to aromatase inhibitors in patients with early-stage breast cancer.
Full Description
OBJECTIVES:
Primary
To determine whether true acupuncture administered twice weekly for 6 weeks (8-12 sessions) compared to sham acupuncture and waitlist control causes a significant reduction in joint pain related to aromatase inhibitors (AIs) in women with early-stage breast cancer as measured by the Brief Pain Inventory-Short Form (BPI-SF) worst pain score at 6 weeks.
Secondary
To investigate the effects of true acupuncture administered twice weekly for 6 weeks (8-12 sessions) followed by 6 weekly treatments (4-6 sessions) of maintenance (12-18 sessions total over 12 weeks) compared to sham acupuncture and waitlist control in this study population; the evaluations at 12 and 24 weeks are to determine the benefit of additional 6 weekly acupuncture treatments for maintenance and to determine the durability of response after stopping acupuncture, respectively; the evaluation at 52 weeks is to determine the long-term effects of acupuncture and adherence to AIs.
To evaluate the effects of acupuncture on the BPI-SF worst pain, worst stiffness, pain severity, and pain-related interference scores at 6, 12, 16, 20, 24, and 52 weeks.
To evaluate the effects of acupuncture on Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index (pain, stiffness, and function) for the hips and knees at 6, 12, 24, and 52 weeks.
To evaluate the effects of acupuncture on Modified-Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) (pain, stiffness, and function) at 6, 12, 24, and 52 weeks.
To evaluate the effects of acupuncture on the PROMIS Pain Impact-Short Form (PROMIS PI-SF) at 6, 12, 24, and 52 weeks.
To evaluate the effects of acupuncture on quality of life (QOL) as assessed by the Functional Assessment of Cancer Therapy-Endocrine Subscales (FACT-ES) at 6, 12, 24, and 52 weeks.
To evaluate the effects of acupuncture on functional testing with grip strength and "Timed Get Up and Go" (TGUG) test at 6, 12, 24, and 52 weeks.
To evaluate the effects of acupuncture on analgesic and opioid use at 2, 4, 6, 12, 16, 20, 24, and 52 weeks.
To evaluate the effects of acupuncture on self-reported AI adherence at 12, 24, and 52 weeks.
To assess AI adherence via urine AI metabolites at baseline, 24, and 52 weeks.
To evaluate the effects of acupuncture on serum hormones (estradiol, FSH, LH) and inflammatory biomarkers (serum TNFα, IL-6, IL-12, CRP, and urine c-telopeptides of Type II collagen (CTX-II) at 6, 12, and 24 weeks. (Exploratory)
To evaluate whether polymorphisms in CYP19A1 aromatase gene predict severity of AI-related joint symptoms. (Exploratory)
To assess the safety and tolerability of acupuncture in this study population.
OUTLINE: This is a multicenter study. Patients are stratified according to study site. Patients are randomized to 1 of 3 treatment arms.
Arm I: Patients receive acupuncture twice weekly for 6 weeks and then once weekly for 6 weeks.
Arm II: Patients receive sham acupuncture twice weekly for 6 weeks and then once weekly for 6 weeks.
Arm III: Patients are assigned to a waiting list for 12 weeks. Patients complete the Brief Pain Inventory-Short Form (BPI-SF), the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, the Modified-Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH), the PROMIS Pain Impact-Short Form (PROMIS PI-SF), the FACT-ES Trial Outcome Index, and the Aromatase Inhibitor Usage Form questionnaires at baseline and at 6, 12, 24 and 52 weeks.
Patients undergo blood sample collection at baseline and at 6, 12, and 24 weeks for serum hormones (estradiol, FSH, LH) levels, inflammatory markers (TNFα, IL-6, IL-12, CRP), and DNA analysis. Urine samples are also collected at baseline and at 24 and 52 weeks for c-telopeptides of Type II collagen and aromatase inhibitor metabolites analysis.
After completion of study treatment, patients are followed up at 24 and 52 weeks.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Patients must be women with histologically confirmed primary invasive carcinoma of the breast (Stage I, II, or III) with no evidence of metastatic disease (M0); patients must have undergone modified radical mastectomy or breast-sparing surgery; patients must have recovered from all side-effects of the surgery
Patients must be positive for estrogen receptor (ER) and/or progesterone receptor (PgR) as determined by institutional standard
Patients must currently be taking a third-generation aromatase inhibitor (AI) - anastrozole, letrozole, or exemestane for at least the previous 90 days prior to registration with plans to continue for at least an additional 1 year after registration; patients may have switched AIs provided that they have been on a stable dose for at least 90 days; concurrent trastuzumab (Herceptin) is allowed
Patients must have completed the S1200 Brief Pain Inventory-Short Form (BPI-SF) within 14 days prior to registration; patients must have a worst pain score of at least 3 on the Brief Pain Inventory (item #2) that has started or increased since starting AI therapy
Patients must be willing to submit blood and urine samples for serum hormones (estradiol, FSH, LH), inflammatory biomarkers (serum TNFα, IL-6, IL-12, CRP and urine CTX-II), urine AI metabolites, and DNA analysis (CYP19A1), and must be given the option to consent to use of remaining specimens for future translational medicine studies; baseline samples must be obtained prior to beginning intervention
PATIENT CHARACTERISTICS:
Patients must be postmenopausal, as defined by at least one of the following:
≥ 12 months since the last menstrual period
Prior bilateral oophorectomy
Current use of a gonadotropin-releasing hormone (GnRH) agonist
Previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) AND follicle-stimulating hormone (FSH) values consistent with the institutional normal values for the postmenopausal state; if patient is under the age of 55, FSH levels must be obtained within 28 days prior to registration
Patients must have a Zubrod performance status of 0 to 1
Patients must not have a severe bleeding disorder
Patients must not have concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including: inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), gout, episodes of acute monoarticular arthritis clinically consistent with pseudogout, Paget disease affecting the study joint (knees/hands), a history of septic arthritis or avascular necrosis or intra-articular fracture of the study joint, Wilson disease, hemochromatosis, alkaptonuria, or primary osteochondromatosis
Patients must not have a history of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to registration
Patients must not have a history of illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient
Patients must be able to complete study questionnaires in English or Spanish
No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ [DCIS], adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for > 5 years
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Patients must not have had prior acupuncture treatment within the past 12 months or for AI-induced joint symptoms at any time
Patients must not be on narcotics within 14 days of registration
Patients must not have received oral corticosteroids, intramuscular corticosteroids, or intra-articular steroids within 28 days prior to registration
Patients must not have received topical analgesics (e.g., capsaicin preparations) or any other analgesics (e.g., opiates or tramadol, with the exception of nonsteroidal anti-inflammatory drugs [NSAIDs] and acetaminophen) within 14 days prior to registration
Patients must not have received or implemented any other medical therapy, alternative therapy, or physical therapy for the treatment of joint pain/stiffness within 28 days prior to registration; therapeutic massage is allowed
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There are 41 Locations for this study
Antioch California, 94531, United States
Fremont California, 94538, United States
Los Angeles California, 90033, United States
Oakland California, 94611, United States
Redwood City California, 94063, United States
Richmond California, 94801, United States
Roseville California, 95661, United States
Sacramento California, 95823, United States
Sacramento California, 95825, United States
San Francisco California, 94115, United States
San Jose California, 95119, United States
San Leandro California, 94577, United States
San Rafael California, 94903, United States
Santa Clara California, 95051, United States
Santa Rosa California, 95403, United States
South San Francisco California, 94080, United States
Stockton California, 95210, United States
Vacaville California, 95688, United States
Vallejo California, 94589, United States
Walnut Creek California, 94596, United States
Boise Idaho, 83712, United States
Meridian Idaho, 83642, United States
Burlington Massachusetts, 01805, United States
Battle Creek Michigan, 49017, United States
Big Rapids Michigan, 49307, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Muskegon Michigan, 49444, United States
Reed City Michigan, 49677, United States
Traverse City Michigan, 49684, United States
New York New York, 10032, United States
Gresham Oregon, 97030, United States
Portland Oregon, 97210, United States
Tualatin Oregon, 97062, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29615, United States
Greer South Carolina, 29650, United States
Seneca South Carolina, 29672, United States
Spartanburg South Carolina, 29307, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98109, United States
Seattle Washington, 98109, United States
Vancouver Washington, 98686, United States
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